MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC. SOL-M TUBE HOLDER WITH LUER LOCK ADAPTER

Model Number	110201050003
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that when attaching this product to the needless adapter tightly and the vacutainer tube inserted, there is no suction.They tried to use it multiple times during blood work.She said that it occured with roughly 10 patients, no specific provided.This was the first time using the adapter.No harm to any patient however, there was a delay in treatment.Possible loff of iu site.
Additional Manufacturer Narrative
The complaint device was not to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.The manufacturing partner checked the batch record of impacted sol-m tube holder with luer lock adapter, ref 110201050003, lot 05109110 with no anomalies found on batch documentation.No samples were received by the customer for evaluation.Archive sample evaluation: visual check: 60pcs of archive samples were visually checked with no anomalies found.Simulation use test: 10pcs of archive samples have been selected to simulate blood collection with 10 times puncturing under 1m static pressure.No anomalies were found in all samples checked.Risk statement: the overall risk assessment, given the severity assessment of s2-minor injury and a probability assessment of p2-low, the final risk priority number of 4.Risk level is in green area/low risk according to our risk management procedure.

• Brand Name: SOL-M TUBE HOLDER WITH LUER LOCK ADAPTER
• Common Device Name: LUER LOCK ADAPTER
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC.; 315 shawnee north drive suite; suite 100; suwanee GA 30024
• Manufacturer (Section G): SOL-MILLENNIUM MEDICAL INC; 315 shawnee north drive; suite 100; suwanee GA 30024
• Manufacturer Contact: shari wiley ; 315 shawnee north drive; suite 100; suwanee, GA 30024 ; 4049732200
• MDR Report Key: 14778313
• Report Number: 3014312726-2022-00001
• Device Sequence Number: 17411729
• Product Code: JKA
• UDI-Device Identifier: 00818392018158
• UDI-Public: 00818392018158
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K163073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2026
• Device Model Number: 110201050003
• Device Lot Number: 05109110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown